OR3O Dual Mobility 71358213Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556712337), received between Jul 10, 2020 and Jun 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED (INSERT ACETABULAR OR3O XLPE OD 36 MM ID22 MM 2 MOBILITY, LINER ACETABULAR OR3O OD 48 MM ID36 MM 2 MOBILITY AND SHELL REDAPT MOD 48MM) WITH A COMPETITOR FEMORAL HEAD (STRYKER); PATIENT SUSTAINED A DISLOCATION OF THE INTERNAL RIGHT HIP PROSTHESIS THAT REQUIRED RE-REVISION SURGERY ON (B)(6) 2021. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19554077 ↗
• InjuryJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED A DISLOCATION OF THE INTERNAL LEFT HIP PROSTHESIS THAT REQUIRED RE-REVISION SURGERY ON (B)(6) 2020. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19553125 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS TAKEN OUT DUE TO AN UNKNOWN ADVERSE TISSUE REACTION. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE.

  Patient problems: Foreign Body Reaction

  MAUDE report 10261032 ↗